ZUMA-2: a phase 2, single-arm, open-label, international study1,3

Pivotal study design 1,3

74

previously treated patients
with R/R MCL
enrolled and leukapheresed

68

patients received
lymphodepleting chemotherapy
and TECARTUS®*

Primary efficacy endpoint:

ORR

Selected secondary endpoints:

DOR, PFS, OS, and safety

Pivotal study design 1,3

74

previously treated patients
with R/R MCL enrolled and leukapheresed

68

patients received
lymphodepleting chemotherapy
and TECARTUS®*

Primary efficacy endpoint:

ORR

Selected secondary endpoints:

DOR, PFS, OS, and safety

  • 60 of the 68 patients who were infused were followed for at least 6 months after their first objective disease response and were evaluable in the efficacy analysis1†
  • Bridging therapy between leukapheresis and lymphodepleting chemotherapy was permitted to control disease burden1,3

Key inclusion criteria1,3

  • Age 18 or older
  • R/R MCL previously treated with anthracycline- or bendamustine-containing chemotherapy, anti-CD20 monoclonal antibody therapy, and a BTKi (ibrutinib or acalabrutinib)
  • Disease progression after the last regimen or refractory to the most recent therapy

Key exclusion criteria1,4

  • Prior allogeneic HSCT, CAR T, and CD19-based therapies
  • Active or serious infections
  • Detectable cerebrospinal fluid malignant cells or brain metastases, and any history of CNS lymphoma or CNS disorders

*Following a lymphodepleting chemotherapy conditioning regimen of cyclophosphamide 500 mg/m2 intravenously and fludarabine 30 mg/m2 intravenously, both given on the fifth, fourth, and third day before treatment, TECARTUS was administered to patients as a single intravenous infusion at a dose of 2 × 106 anti-CD19 CAR T cells/kg (maximum permitted dose: 2 × 108 cells).1

Among the 60 efficacy-evaluable patients, 2 x 106 CAR-positive viable T cells/kg were administered to 54 patients (90%). The remaining 6 patients (10%) received doses of 1.0, 1.6, 1.8, 1.8, 1.9, and 1.9 x 106 CAR-positive viable T cells/kg.1


TECARTUS was studied in a range of patients with R/R MCL—a historically difficult-to-treat population1,5,6

Key characteristics of ZUMA-2 (n=68)3

Y E A R S 65
Median age (range: 38-79)
100 %
R/R on or after a BTKi
43 %
Relapsed after ASCT
17 %
TP53 mutation (n=6/36)
31 %
Blastoid/pleomorphic morphology (n=21/68)
82 %
Ki-67 index ≥30% (n=40/4)
  • Patients had a median of 3 prior therapies3

High-risk characteristics were common in patients enrolled in the registration trial3

These characteristics were deemed high-risk in the ZUMA-2 trial. TP53 mutation and Ki-67 index ≥30% rates were based on patients with evaluable samples (n=36 and n=49, respectively). Please see the USPI for additional patient characteristics.3

ASCT=autologous stem cell transplant; BTKi=Bruton’s tyrosine kinase inhibitor; CAR=chimeric antigen receptor; CD=cluster of differentiation; CNS=central nervous system; DOR=duration of response; HSCT=hematopoietic stem cell transplant; MCL=mantle cell lymphoma; ORR=objective response rate; OS=overall survival; PFS=progression-free survival; R/R=relapsed or refractory; USPI=US Prescribing Information.

References: 1. TECARTUS® (brexucabtagene autoleucel). Prescribing information. Kite Pharma, Inc; 2021. 2. Wang M, Munoz J, Goy A, et al. Three-year follow-up of KTE-X19 in patients with relapsed/refractory mantle cell lymphoma, including high-risk subgroups, in the ZUMA-2 study. J Clin Oncol. 2023;41(3):555-567. 3. Wang M, Munoz J, Goy A, et al. KTE-X19 CAR T-cell therapy in relapsed or refractory mantle cell lymphoma. N Engl J Med. 2020;382(14):1331-1342. 4. Wang M, Munoz J, Goy A, et al. KTE-X19 CAR T-cell therapy in relapsed or refractory mantle cell lymphoma – study protocol. N Engl J Med. 2020;1-47. 5. Kumar A, Sha F, Toure A, et al. Patterns of survival in patients with recurrent mantle cell lymphoma in the modern era: progressive shortening in response duration and survival after each relapse. Blood Cancer J. 2019;9(50):1-10. 6. Dreyling M, Shah B, Wu J, et al. Unmet need in relapsed/refractory (R/R) mantle cell lymphoma (MCL) post-Bruton tyrosine kinase inhibitor (BTKi): a systematic literature review and meta-analysis. Abstract 603. Abstract presented at the International Conference on Malignant Lymphoma; June 13-17, 2023; Lugano, Switzerland.